Recall Z-1070-2016— ConforMIS, Inc.

Name: FDA recall Z-1070-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-28

Class II · Terminated

Class II FDA medical device recall by ConforMIS, Inc., initiated 2016-01-28, terminated 2016-03-09. It names one FDA 510(k) clearance: K142161. Product: Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111. Reason: Incorrect femoral component distributed.

Recalling firm: ConforMIS, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-01-28
Terminated: 2016-03-09
Firm location: Bedford, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K142161 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEMConformis, Inc.·cleared 2014-11-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111

Reason for recall

Incorrect femoral component distributed

Data sourced from openFDA. This site is unofficial and independent of the FDA.